BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VEINOPLUS NEUROMUSCULAR STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern

    FDA 510(k)
    FDA Class 2 ·Immunology

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 13, 2014

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 12, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 13, 2012

    icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.

    FDA Enforcement
    Class I ·Terminated·ICU Medical, Inc.·April 24, 2019